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Thrombin-receptor antagonist vorapaxar in acute coronary syndromes.

Publication ,  Journal Article
Tricoci, P; Huang, Z; Held, C; Moliterno, DJ; Armstrong, PW; Van de Werf, F; White, HD; Aylward, PE; Wallentin, L; Chen, E; Lokhnygina, Y ...
Published in: N Engl J Med
January 5, 2012

BACKGROUND: Vorapaxar is a new oral protease-activated-receptor 1 (PAR-1) antagonist that inhibits thrombin-induced platelet activation. METHODS: In this multinational, double-blind, randomized trial, we compared vorapaxar with placebo in 12,944 patients who had acute coronary syndromes without ST-segment elevation. The primary end point was a composite of death from cardiovascular causes, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization. RESULTS: Follow-up in the trial was terminated early after a safety review. After a median follow-up of 502 days (interquartile range, 349 to 667), the primary end point occurred in 1031 of 6473 patients receiving vorapaxar versus 1102 of 6471 patients receiving placebo (Kaplan-Meier 2-year rate, 18.5% vs. 19.9%; hazard ratio, 0.92; 95% confidence interval [CI], 0.85 to 1.01; P=0.07). A composite of death from cardiovascular causes, myocardial infarction, or stroke occurred in 822 patients in the vorapaxar group versus 910 in the placebo group (14.7% and 16.4%, respectively; hazard ratio, 0.89; 95% CI, 0.81 to 0.98; P=0.02). Rates of moderate and severe bleeding were 7.2% in the vorapaxar group and 5.2% in the placebo group (hazard ratio, 1.35; 95% CI, 1.16 to 1.58; P<0.001). Intracranial hemorrhage rates were 1.1% and 0.2%, respectively (hazard ratio, 3.39; 95% CI, 1.78 to 6.45; P<0.001). Rates of nonhemorrhagic adverse events were similar in the two groups. CONCLUSIONS: In patients with acute coronary syndromes, the addition of vorapaxar to standard therapy did not significantly reduce the primary composite end point but significantly increased the risk of major bleeding, including intracranial hemorrhage. (Funded by Merck; TRACER ClinicalTrials.gov number, NCT00527943.).

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Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

January 5, 2012

Volume

366

Issue

1

Start / End Page

20 / 33

Location

United States

Related Subject Headings

  • Receptor, PAR-1
  • Pyridines
  • Platelet Aggregation Inhibitors
  • Middle Aged
  • Male
  • Lactones
  • Kaplan-Meier Estimate
  • Intracranial Hemorrhages
  • Humans
  • Hemorrhage
 

Citation

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Tricoci, P., Huang, Z., Held, C., Moliterno, D. J., Armstrong, P. W., Van de Werf, F., … TRACER Investigators, . (2012). Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med, 366(1), 20–33. https://doi.org/10.1056/NEJMoa1109719
Tricoci, Pierluigi, Zhen Huang, Claes Held, David J. Moliterno, Paul W. Armstrong, Frans Van de Werf, Harvey D. White, et al. “Thrombin-receptor antagonist vorapaxar in acute coronary syndromes.N Engl J Med 366, no. 1 (January 5, 2012): 20–33. https://doi.org/10.1056/NEJMoa1109719.
Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, et al. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med. 2012 Jan 5;366(1):20–33.
Tricoci, Pierluigi, et al. “Thrombin-receptor antagonist vorapaxar in acute coronary syndromes.N Engl J Med, vol. 366, no. 1, Jan. 2012, pp. 20–33. Pubmed, doi:10.1056/NEJMoa1109719.
Tricoci P, Huang Z, Held C, Moliterno DJ, Armstrong PW, Van de Werf F, White HD, Aylward PE, Wallentin L, Chen E, Lokhnygina Y, Pei J, Leonardi S, Rorick TL, Kilian AM, Jennings LHK, Ambrosio G, Bode C, Cequier A, Cornel JH, Diaz R, Erkan A, Huber K, Hudson MP, Jiang L, Jukema JW, Lewis BS, Lincoff AM, Montalescot G, Nicolau JC, Ogawa H, Pfisterer M, Prieto JC, Ruzyllo W, Sinnaeve PR, Storey RF, Valgimigli M, Whellan DJ, Widimsky P, Strony J, Harrington RA, Mahaffey KW, TRACER Investigators. Thrombin-receptor antagonist vorapaxar in acute coronary syndromes. N Engl J Med. 2012 Jan 5;366(1):20–33.

Published In

N Engl J Med

DOI

EISSN

1533-4406

Publication Date

January 5, 2012

Volume

366

Issue

1

Start / End Page

20 / 33

Location

United States

Related Subject Headings

  • Receptor, PAR-1
  • Pyridines
  • Platelet Aggregation Inhibitors
  • Middle Aged
  • Male
  • Lactones
  • Kaplan-Meier Estimate
  • Intracranial Hemorrhages
  • Humans
  • Hemorrhage